FEATURE TEST & MEASUREMENT


Don’t pay lip service to your CE marking technical file


CE marking is a three step process – affixing the CE marking onto the product, the Declaration of Conformity and the technical file. The third stage is often overlooked or paid lip service by manufacturers, yet it is the most important element that will provide evidence of compliance, explains Richard Poate, senior compliance manager at TÜV SÜD


E


uropean harmonised standards detail technical tests and design


requirements to meet the essential requirements of more than 20 European Union (EU) directives. This is so that products and components, including electrical and electronic items, can display the CE marking and be sold in the EU. The affixing of the CE marking to a product is the manufacturer’s declaration that it meets the necessary requirements. This is supported by the Declaration of Conformity (DoC), which must be signed by a responsible person within the organisation. Interestingly neither of these stages is evidence of compliance. The third stage of the process - the technical file - is often overlooked, despite providing this proof. Electrical products being tested in TÜV


SÜD’s laboratories are regularly failing the simplest of tests. Non-compliant products identified by Trading Standards are just the tip of the iceberg as they, and other surveillance authorities across Europe, do not have the resources to check the millions of shipments that enter the EU and UK every year.


WHAT IS A TECHNICAL FILE? A technical file is documented evidence to show that the product complies with the requirements of the Directives that apply to it. We see a wide variety of approaches to technical files – everything from a single page to a pile of papers. Of course, there is a middle ground that can be reached through understanding the importance and relevance of a technical file within the CE marking process. A good starting point is the EU’s ‘Blue


Guide’ on the implementation of EU product rules, which outlines the type of documents that surveillance authorities would expect to find in a technical file. The manufacturer must establish the technical documentation, which shows how the essential requirements of the relevant Directives have been met. The importer must ensure the manufacturer has met their obligations, including the


1 MAY 2017 | ELECTRICAL ENGINEERING 6 A good technical file must cover the


design, manufacture and operation of the products"


provision of a technical file that can be provided to the surveillance authorities on demand. If a product is re-branded, so that


there is no traceability to the original manufacturer, then the company that has re-branded the product takes on the responsibilities of the manufacturer. They must issue their own declaration of conformity and technical documentation to prove compliance. The documentation within the


technical file must enable enforcement authorities to assess the conformity of the product. It is important to remember that they will not be highly skilled electrical engineers, so plain language must be used and explanations given. They are also entitled to demand the technical file is provided in any EU language, so be prepared to translate it. The technical file can be a traditional


paper file, or stored electronically, with hyperlinks to documents. It must also be


kept up-to-date as the product is adapted, which means that the technical file cannot be put away and forgotten and must be retained for 10 years. A good technical file must cover the


design, manufacture and operation of products and include a general description of the product, the conceptual design/block diagram of what it is, and a full set of manufacturer’s drawings, descriptions and explanations of the design. It should also include the operation of the product, a list of the standards applied, the solutions adopted to satisfy them and a list of components, as well as the results of the design calculations made and examinations carried out. Regarding the test reports, while there is no requirement to use an accredited laboratory for this stage, if the manufacturer decides to do the tests themselves, they must prove it was carried out by a competent person with the appropriate equipment. The technical file is the first document


that the authorities will ask for as it provides vital evidence that the correct procedures have been taken during product development. Enforcing authorities vary and may include the Health and Safety Executive for machinery, pressure vessels and ATEX, the Medicines and Healthcare products Regulatory Agency (MRHA), and the Office of Communications (Ofcom) for protection and management of the radio spectrum. Trading Standards spot-check goods


entering the UK, as businesses importing into the EU are required to hold evidence of the test reports and certificates to prove compliance in the form of the technical file. If such information is missing, this may result in prosecution. Businesses have a legal responsibility for ensuring proof of compliance and without it, the manufacturer, importer or retailer could face significant fines or even imprisonment.


TÜV SÜD www.tuv-sud.co.uk


/ ELECTRICALENGINEERING


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